NCT02776137已完成2 期
Postoperative Concurrent Chemoradiotherapy With Docetaxel for High-Risk Squamous Cell Carcinoma of Head and Neck，A Non-Randomized Phase II Trial
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2016年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
This is a non-randomized, phase II, open label study of postoperative concurrent chemoradiotherapy with docetaxel for high-risk squamous cell carcinoma of the head and neck(HNSCC).The primary purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy with docetaxel in HNSCC patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed squamous cell carcinoma of the head and neck.Site of tumor origin in the oral cavity, oropharynx, larynx, or hypopharynx (excluding nasopharynx, or sinuses)
- •Gross total resection, with pathology demonstrating one or more of the following risk factors:
- •Histologic extracapsular nodal extension
- •Histologic involvement of ≥ 2 regional lymph nodes
- •Invasive cancer seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual
- •No evidence of distant metastases
- •No synchronous or concurrent head and neck primary tumors
- •Karnofsky score over 60
- •Adequate organ function including the following:
- •Absolute neutrophil count (ANC) >= 1.5 * 10^9/l
- •Platelets count >= 100 * 10^9/l
- •Hemoglobin >= 10 g/dl
- •AST and ALT <= 2.5 times institutional upper limit of normal (ULN)
- •Total bilirubin <= 1.5 times institutional ULN
- •Creatinine clearance >= 50 ml/min
- •Serum creatine <= 1 times ULN
- •Signed written informed consent
排除标准
- •Evidence of distant metastasis
- •Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
- •Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
- •Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
- •Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
研究组 & 干预措施
Docetaxel Group
Experimental
Concurrent Chemoradiotherapy With Docetaxel
干预措施: Docetaxel (Drug)
Docetaxel Group
Experimental
Concurrent Chemoradiotherapy With Docetaxel
干预措施: Intensity-modulated radiotherapy (Radiation)
结局指标
主要结局
Disease-free survival
时间窗: 2 years
from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years
次要结局
- overall survival rate(2 years)
- Acute toxicity profiles, graded according to the NCI CTCAE version 3.0(up to 6-7 weeks)
- Late toxicity profiles, graded according to the NCI CTCAE version 3.0(up to 2 years)
- Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment(participants will be followed for the duration of hospital stay, an expected average of 6 weeks)
研究者
Guopei Zhu
M.D.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
研究点 (1)
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